PROXERA PSOMED 30 Nail Psoriasis Trial, 21 Participants, 24 Weeks
ClinicalTrials.gov Studies
Summary
ClinicalTrials.gov has registered a Phase IV interventional study evaluating PROXERA PSOMED 30, a 30% urea topical medical device, for the treatment of nail psoriasis in adults. The randomized controlled trial will enroll 21 participants aged 18-65 and compare active treatment against petrolatum (Vaseline) control over 24 weeks, measuring improvements in Nail Psoriasis Severity Index (NAPSI) scores as the primary efficacy endpoint. Participants will apply treatments twice daily to target nails with follow-up assessments at baseline, week 4, week 12, and week 24.
“The purpose of this interventional clinical study is to evaluate the safety and efficacy of PROXERA PSOMED 30, a topical medical device containing 30% urea, for the treatment of nail psoriasis in adults with nail psoriasis.”
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What changed
This ClinicalTrials.gov registry entry documents a new Phase IV interventional clinical study for PROXERA PSOMED 30, a topical medical device containing 30% urea, intended for nail psoriasis treatment. The 24-week randomized controlled trial will compare the device against petrolatum (Vaseline) control in 21 adult participants, assessing efficacy via NAPSI score improvements and tolerability. Regulatory affairs and clinical operations teams tracking medical device development pipelines should note this as an active clinical investigation in the dermatology/nail psoriasis therapeutic area. The study specifies inclusion criteria of nail psoriasis duration at least 6 months and a target NAPSI nail score of 3 or higher at baseline.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy
N/A NCT07546032 Kind: NA Apr 22, 2026
Abstract
The purpose of this interventional clinical study is to evaluate the safety and efficacy of PROXERA PSOMED 30, a topical medical device containing 30% urea, for the treatment of nail psoriasis in adults with nail psoriasis. The primary question the study aims to answer is whether PROXERA PSOMED 30 improves the clinical signs of nail psoriasis more effectively than a control treatment (Vaseline).
Researchers will compare two similar target nails in the same participant, one treated with PROXERA PSOMED 30 and the other with Vaseline, to determine whether the active treatment leads to greater improvement in Nail Psoriasis Severity Index (NAPSI) scores over 24 weeks. The study will also evaluate local tolerability, patient satisfaction, and digital photographs of the treated nails.
Participants will be men or women between the ages of 18 and 65 with nail psoriasis for at least 6 months and a target NAPSI nail score of 3 or higher. A total of 21 participants is expected.
Participants will:
apply PROXERA PSOMED 30 to one target nail and petroleum jelly to the opposite target nail twice daily for 24 weeks; attend follow-up visits at baseline and after 4, 12, and 24 weeks; undergo nail assessments using the NAPSI score; have digital photographs of treated nails; report tolerability, satisfaction, and any adverse events during the study.
Conditions: Nail Psoriasis
Interventions: Device intervention name: PROXERA PSOMED 30 nail cream; Control intervention name: Petrolatum
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